• CLINICAL INTEREST SECTIONS: Congenital Coronary Peripheral SCAI TAVR Center

  • SCAI This Week
  • March 22, 2013

    In This Issue:

     


     

     


     

    SCAI Comments on FDA Panel Recommendation to Approve MitraClip

    In a statement issued yesterday SCAI commends the the thoughtful deliberations and ultimate recommendation for approval by the Food and Drug Administration (FDA) Circulatory System Devices Panel during proceedings regarding the MitraClip Delivery System on Wednesday.

    The MitraClip was being considered for treatment for patients with significant mitral regurgitation who are determined to be too high risk for open mitral valve surgery and in whom co-morbidities would not preclude the expected benefit. The panel was unanimous in their vote that the MitraClip is safe for use in such patients. In a split vote, the panel ultimately recommended approval of the device for the proposed indication. Like the majority of the panelists, SCAI believes that MitraClip therapy is safe and that its benefits outweigh the risks for patients who meet these criteria and have no other treatment options available to them.

    As Augusto Pichard, MD, FSCAI, conveyed when he delivered SCAI testimony, SCAI urges the FDA to follow the advisory panel's recommendation to approve the MitraClip Delivery System for these patients, with the following requirements:

    • MitraClip therapy should be offered only to symptomatic patients with severe (> 3+) mitral regurgitation who are determined to be too high risk for open mitral valve surgery and in whom co-morbidities would not preclude the expected benefit.
    • The heart team approach with collaboration among surgery, cardiology and other medical professionals is recommended as the mechanism for deciding therapy for the patient.
    • All patients treated with MitraClip therapy must be entered into the TVT nationwide registry to track real-world outcomes and answer questions not addressed by clinical trial.
    • Prospective randomized trials should be conducted to assess the impact of MitraClip therapy on heart failure.

    Read Dr. Pichard's Testimony

    Watch Dr. Pichard Discuss the Benefits of MitraClip With Cardiology News

    Read SCAI's Statement on the FDA Devices Panel Decision

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    SCAI Leaders Discuss JAMA Study Showing PCI's Healthcare Savings

    In a press release issued yesterday, SCAI leaders comment on a study published this week in the Journal of the American Medical Association (JAMA) Surgery that found dramatic health plan cost savings and reduced workplace absences associated with minimally invasive procedures versus major surgery. Among six procedures examined, PCI led the way in savings to employer-sponsored health insurance plans and reduced absenteeism. Over the course of one year, PCI saved health plans $30,850 per patient and reduced the number of work days missed by 37.7 per patient compared to CABG. Peripheral revascularization also made significant contributions to the saving associated with minimally invasive procedures, costing employers $12,031 less per patient in costs to health plans and 16.6 fewer days out of work per patient, vs. open surgery.

    Collectively, the minimally invasive procedures analyzed in the study reduced health plan expenditures by more than $8.9 billion and another $2.2 billion in reduced workplace absenteeism over a one-year period nationally among adults with employer-sponsored health insurance.

    The researchers, led by Andrew J. Epstein, Ph.D., of the University of Pennsylvania, focused on a sample of 321,956 adults ages 18 to 64 years enrolled in employer-sponsored health insurance plans. They assessed health plan expenditures for medical and pharmacy costs, as well as days absent from work, including vacation, sick leave, and short-term disability.

    “We wanted to look at this issue because we saw a gap in discussions of what value really means in medical care,” said Dr. Epstein. “Clinical outcomes are obviously important, but they shouldn’t be the sole measure of potential benefit. Recovery times also matter. How quickly people can get back to work, and the effects on their employers’ bottom-lines, are both real and important factors for assessing value.”

    Dr. Epstein and SCAI Trustee Cindy Grines, MD, FSCAI, fielded several media interviews on the study this week. In addition to early media coverage of the study is compiled below, SCAI has disseminated video featuring SCAI President J. Jeffrey Marshall, MD, FSCAI, discussing the study's findings with Dr. Grines.

    Watch the Video & Read SCAI's Press Release

    Read the JAMA Surgery Abstract

    Media Coverage as of this Morning:

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    SCAI 2013: Stay on Track With Quality, Coronary, Peripheral, CHD & SHD

    At SCAI 2013 Scientific Sessions, interventional cardiologists and their cath lab teams will stay right on track, thanks to the easy-to-navigate program organized around the following stand-alone tracks:

    • NEW! Quality Improvement Track
      “The Qualit yMandate: Understanding New Regulatory Policies and Establishing Interventional Cardiologists as Quality Superheroes” will set the stage for this brand new track. Subsequent sessions will address “How to Be a Quality and Safety Champion in the Cath Lab” and “Talking the Talk and Walking the Walk,” where discussion will focus on quality metrics and accreditation. Other highlights: ethical challenges, payment reform, public reporting, and peer review.

    • Congenital Heart Disease Track
      One highlight of this track will be a session called “One Year After the FDA Circulatory Device Panel: What Did It Do?” Other sessions will include “Thirty Years of Experience: What Have We Learned?,” “New Toys and Technology,” “New Procedures: Benefits vs. Risks,” and the always-popular “I Blew It.”

    • Coronary Track
      Focus areas of this track will include radial artery access interventions and chronic total
      occlusions (CTOs). Other don’t-miss sessions will include “Worst Nightmares and Best Saves,” “Hottest Topics 2013,” “Controversies in Revascularization: Left Main, PCI vs. CABG, and Trials,” “All You Wanted to Know About Treating Complex Angiographic Subsets,” and “Exceptional Challenges in PCI: Case Reviews Demonstrating Newest Techniques and Technologies.”

    • Peripheral Track
      One major emphasis of this track will be critical peripheral ischemia syndromes, with sessions addressing the lower extremity as well as the mesenteric, renal, and cerebrovascular. The track also will include “From Angiosomes to Renal Denervation: What’s New in Peripheral Interventions?”, “Eye on Aortic Intervention: AAA, Dissection, and Other Syndromes,” and “How the Experts Do It: Latest and Best Peripheral Vascular Disease Techniques.”

    • Structural Track
      Kicking off with SCAI’s annual hemodynamics symposium, this track will include a focus on transcatheter aortic valve replacement (TAVR), including how to start a TAVR program followed by a mini symposium offering basic, intermediate, and advanced information on TAVR. Other sessions will focus on cath lab imaging beyond angiography, mitral valve interventions, vascular access, structural heart nightmares, and the best “saves” of the past year.

    Register for SCAI 2013 - Advance Registration Rate Ends March 27

    Download the Advance Program

    Act Now! Discounted Room Block at The Peabody Orlando is Filling Quickly

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    SCAI 2013: Congenital Program Chair Calls for Your Best Cases

    The simple concept behind the "I Blew It" & "Brain Scratchers" sessions at SCAI 2013's Congenital Heart Disease Symposium is that there is no better teaching method than coming together as a community and sharing our unusual and challenging cases.

    The "I Blew It" Sessions will be returning for the 14th year to educate with all the ways interventional cases can go awry and with the creative ways that our colleagues manage these complications. More importantly, the session addresses how to avoid such events in the future.

    The "Brain Scratchers" Session challenges attendees to solve hemodynamic, angiographic or interventional mysteries and to provide solutions for less than routine cases in the congenital catheterization laboratory.

    If you have a case that might be a good learning tool for either session, please contact Thomas Fagan, MD, FSCAI, at Thomas.Fagan@childrenscolorado.org. The presentation should last no more than a total of 10 minutes including a dialogue with participants and moderators in how to deal with the complication. The presentation should conclude with some teaching points.

    Join the Best of the Best in Congenital Interventions - Register for SCAI 2013

    More Information on the CHD Symposium at SCAI 2013

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    Two Percent Sequestration Cuts to Medicare Payments Begin April 1

    Absent Congressional action, the Budget Control Act of 2011 includes provision requiring mandatory cuts in Federal spending, known as “sequestration” that were initially slated to go into effect at the beginning of this year. The American Taxpayer Relief Act of 2012 successfully provided temporary relief from “sequestration” for the first two months of 2013. But, now time has run out, and with Congress still unable to reach a compromise, as required by law, President Obama issued a sequestration order on March 1, 2013.

    Included in the across-the-board sequestration cuts is a 2% reduction in all Medicare fee-for-service program payments. CMS has provided notice that they will start applying the 2% reduction in Medicare payment to claims for dates of service or dates of discharge on or after April 1, 2013. Per CMS, the 2% reduction in payment will only be applied after determining coinsurance, any applicable deductible, and any applicable Medicare Secondary Payment adjustments. Though beneficiary payments for deductibles and coinsurance are not subject to the 2% payment reduction, Medicare’s payment to beneficiaries for unassigned claims are.

    View the CMS Notice Regarding the Sequestration Cut

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    Mastering FFR-IVUS Online Curriculum Launches its March Module!

    Last month SCAI introduced its Mastering FFR-IVUS Online Curriculum, featuring Course Director Morton Kern, MD, FSCAI and Course Co-Director Allen Jeremias, MD, FSCAI. Like other courses in SCAI's growing eLearning Library, the FFR/IVUS course material is a complimentary benefit available to all SCAI members. CME credit will be available for purchase after all of the modules have been released.

    This latest addition to the Society's menu of online educational offerings features an all-new twist: the release of a new curriculum module every month.

    Designed to ensure learners master the curriculum and build on competencies as they are introduced this monthly release schedule will also allow for flexibility to continuously enhance the program while ensuring the content remains both current and comprehensive.

    March's new module, "Technical Performance of FFR and Eliminating Pitfalls," presented by Dr. Kern is now available online. This presentation focuses on the technical set up for using FFR, reviews concepts in pressure wire measurements, and examines factors in producing erroneous signals.

    Access the March Module Now!

    More Information on SCAI's Mastering FFR-IVUS Online Curriculum

    Visit the SCAI eLearning Library


    Acknowledgments:

    SCAI would like to recognize the following partners for providing an educational grants in support of the Mastering IVUS-FFR Online Course:

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